CRANIOTOMY PACK, Pack Number DYNJ46552O
Reported: September 18, 2024 Initiated: June 18, 2024 #Z-3069-2024
Product Description
CRANIOTOMY PACK, Pack Number DYNJ46552O
Reason for Recall
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 188 units
- Distribution
- US: TX, IL, CA
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
CRANIOTOMY PACK, Pack Number DYNJ46552O. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 188 units.
Why was this product recalled? ▼
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3069-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11